REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION— 510(k) K952395

Name: FDA 510(k) clearance K952395
Creator: U.S. Food and Drug Administration
Published: 1995-08-15

Substantially Equivalent

Contour Fabricators of Florida, Inc.

FDA 510(k) clearance K952395 for REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION, Substantially Equivalent on 1995-08-15. Applicant: Contour Fabricators of Florida, Inc.. Device class: 1.

Clearance details

Applicant: Contour Fabricators of Florida, Inc.
Product code: Code BSY
Device class: Class 1
Regulation: 21 CFR 868.6810
Advisory panel: Anesthesiology
Date received: 1995-05-22
Decision date: 1995-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Petersburg, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BSY

view all

K031997 — MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM2003-11-25
K992902 — AMBU HAND POWER SUCTION PUMP1999-10-25
K982945 — DUAL PURPOSE CLOSED CATHETER1998-09-22
K981910 — SUCTION CATHETER1998-08-24
K972258 — HI-CARE CLOSED SUCTION SYSTEM1997-12-29

More clearances from Contour Fabricators of Florida, Inc.

view all

K955685 — RNS STERILE, DISPOSABLE CT BIOPSY TRAY1996-10-04
K962040 — RNS ARTHROGRAM TRAY1996-06-25
K955687 — RNS STERILE, DISPOSABLE RADIOGRAPHIC CONTRAST TRAY1996-06-03
K955689 — RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY1996-05-15
K955684 — RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY1996-05-02

Adverse events under product code BSY

product code BSY

Death: 3
Injury: 155
Malfunction: 959
Total: 1,117

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.